Post marketing surveillance stepped up in Singapore: Dr Raymond Chua

Over the last two years, the statistics for new drug approval has been on the lower side and generics drugs are on the rise. In 2009, 102 new drugs were approved in Singapore. The number came down to 90 in 2010 and stood at 84 in 2011. On the other hand, the count of generic drugs approved in 2009 was 57, which went up to 73 in 2011. For new drug approval, two percent came through full evaluation, 89 percent through abridged evaluation and nine percent through verification, whereas for generic drugs, 100 percent was approved by abridged evaluation.

The HSA has international collaborations with many agencies. What is the structure of the collaborations?

The HSA's collaborations with different agencies are at different levels. We have memoranda of understanding for exchange of information and training with agencies such as Interpol, and work sharing initiatives such as parallel evaluation and joint GMP inspections. We have mutual recognition arrangements with the Therapeutic Goods Administration on GMP inspection and a partnership with World Health Organization for international medical products anti-counterfeiting task force. We also work with overseas drug regulatory agencies such as Pharmaceutical Inspection Co-operation Scheme.

There are over 10 different regulatory agencies with which the HSA has relations for exchange of information, building capacity and capability, keeping checks on adulteration and counterfeit information sharing. Some of the partners are National Pharmaceutical Control Bureau of Malaysia, Korea FDA, China SFDA, US Pharmacopeia, Swiss Medic and UK MHRA. Singapore is working on harmonizing regulatory requirements with ASEAN and international guidelines.

How many cases of illegal drugs have been reported in Singapore recently?